Treatment for recurrent and refractory solid tumors using IMA402
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific TCER® Targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
This study is testing a new treatment called IMA402 to see if it can help people with advanced solid tumors that haven't responded to other therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 145 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Immatics Biotechnologies GmbH Industry-sponsored |
| Locations | 24 sites (Heidelberg, Baden-Wurttemberg and 23 other locations) |
| Trial ID | NCT05958121 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and anti-tumor activity of IMA402, a T Cell-Engaging Receptor Molecule, in patients with recurrent and/or refractory solid tumors. The study is conducted in two phases: Phase Ia focuses on dose escalation to determine the maximum tolerated dose, while Phase Ib and II assess the drug's efficacy and safety in specific cohorts. Patients must have advanced solid tumors that have not responded to standard treatments, and the study will monitor their response to IMA402 over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors that have not responded to standard treatments.
Not a fit: Patients with other active malignancies requiring treatment or those with severe uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.
How similar studies have performed: Other studies using T Cell-Engaging Receptor Molecules have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years old * Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication * Patients must have received or not be eligible for all available indicated standard-of-care treatments * Measurable disease according to RECIST 1.1 * Confirmed HLA status * ECOG Performance Status of 0 to 1 * Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status Exclusion Criteria: * Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed) * The patient is pregnant or is breastfeeding * History of hypersensitivity to components of IMA402 or rescue medications, if no alternative treatment option is available * The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures * Patients with active brain metastases
Where this trial is running
Heidelberg, Baden-Wurttemberg and 23 other locations
- Universitaetsklinikum Heidelberg AöR — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
- Universitaetsklinikum Mannheim GmbH — Mannheim, Baden-Wurttemberg, Germany (Recruiting)
- Universitaetsklinikum Ulm AöR — Ulm, Baden-Wurttemberg, Germany (Recruiting)
- Universitaetsklinikum Erlangen AöR — Erlangen, Bavaria, Germany (Recruiting)
- Klinikum Nürnberg — Nuremberg, Bavaria, Germany (Recruiting)
- Universitaetsklinikum Regensburg — Regensburg, Bavaria, Germany (Recruiting)
- Universitaetsklinikum Wuerzburg AöR — Würzburg, Bavaria, Germany (Recruiting)
- Justus-Liebig-Universitaet Giessen — Giessen, Hesse, Germany (Recruiting)
- Philipps-Universitaet Marburg — Marburg, Hesse, Germany (Recruiting)
- Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH — Buxtehude, Lower Saxony, Germany (Recruiting)
- Universitaetsklinikum Bonn AöR — Bonn, North Rhine-Westphalia, Germany (Recruiting)
- Marien Hospital Duesseldorf GmbH — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
- KEM I Evang. Kliniken Essen-Mitte gGmbH — Essen, North Rhine-Westphalia, Germany (Recruiting)
- Universitaetsklinikum Essen AöR — Essen, North Rhine-Westphalia, Germany (Recruiting)
- Johannes Wesling Klinikum Minden — Minden, North Rhine-Westphalia, Germany (Recruiting)
- Universitaet Muenster — Münster, North Rhine-Westphalia, Germany (Not_yet_recruiting)
- Klinikum Chemnitz gGmbH — Chemnitz, Saxony, Germany (Recruiting)
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR — Dresden, Saxony, Germany (Recruiting)
- University Of Leipzig — Leipzig, Saxony, Germany (Recruiting)
- Universitaetsklinikum Magdeburg AöR — Magdeburg, Saxony-Anhalt, Germany (Recruiting)
- Antoni von Leeuwenhoek- Netherlands Cancer Institute — Amsterdam, North Holland, Netherlands (Recruiting)
- Leiden Universitair Medisch Centrum — Leiden, South Holland, Netherlands (Recruiting)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (Recruiting)
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Immatics Biotechnologies GmbH
- Email: Ctgovinquiries@immatics.com
- Phone: Please E-Mail
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.